Purpose of the RATIONALE-302 Study
The primary end point was Survival in all patients.
Patients and Methods
In this phase III clinical study, patients with advanced or metastatic esophageal squamous cell carcinoma, whose tumor progressed after first systemic treatment, were randomly assigned to receive Tislelizumab or chemotherapy (investigator’s choice of Taxol, Taxotere, or Irinotecan).
In total, 512 patients were recruited.
In patients with TAP ≥ 10%, the Survival was 10.3 vs 6.8 months and the risk of death decreased by 46%.
Treatment with Tislelizumab was associated with higher response rate (20.3% vs 9.8% of patients who experienced disease control and/or decrease in lesion volume due to the treatment) and a more durable antitumor response (7.1 vs 4.0 months) in all patients.
Fewer patients experienced harsh treatment-related side effects (18.8% vs 55.8%) with Tislelizumab versus chemotherapy.
Tislelizumab demonstrated a tolerable safety profile.
These findings suggest that Tislelizumab is an effective and safe therapy in patients with advanced or metastatic ESCC after progression on first-line therapy and should be considered in this patient population.
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